Pradaxa®: First NOAC to be assessed in prospective study in patients with blood clots in the veins or venous sinuses of the brain

Results will assist physicians in selecting an appropriate oral anticoagulant for acute treatment and secondary prevention of blood clots in the veins or venous sinuses of the brain1

Ingelheim, Germany, 11 May 2016 – Boehringer Ingelheim will undertake the first prospective, randomised controlled study of a non-vitamin K antagonist oral anticoagulant (NOAC) in patients with blood clots in the veins or venous sinuses of the brain. RE-SPECT CVT® will investigate the safety and efficacy of dabigatran etexilate (Pradaxa®) compared to warfarin for acute treatment and secondary prevention of cerebral venous thrombosis (CVT). The new study was announced at the 2nd European Stroke Organisation Conference 2016 in Barcelona, Spain.1

Cerebral venous thrombosis (CVT) occurs when a blood clot forms in the brain’s veins or venous sinuses, the channels that drain blood from the brain. If these veins or channels become blocked, blood is unable to leave the brain. This can lead to an increase in intracranial blood pressure, congestion and leakage of blood into the brain tissues, which can eventually lead to a haemorrhagic stroke.2

Although relatively rare, CVT requires immediate medical attention and can lead to serious long term complications.2 Standard therapy for acute CVT treatment and secondary prevention of recurrent blood clots currently involves anticoagulation with unfractionated or low-molecular-weight heparin, followed by a vitamin K antagonist (VKA - warfarin).1 Dabigatran etexilate has already been shown to be effective in the treatment and prevention of other types of blood clots with a favourable safety profile compared to VKA therapy.3-7 RE-SPECT CVT® will investigate whether dabigatran etexilate also provides treatment advantages to patients with CVT.1

“We are very excited about this new study. Patients with CVT need effective treatment and we believe that they can benefit from recent advances in anticoagulation care,” advised Prof. José M. Ferro, Department of Neurosciences and Mental Health, Hospital Santa Maria, Lisbon, Portugal. “The RE-SPECT CVT® study will provide physicians with additional knowledge to address unmet medical need in this indication.”

The RE-SPECT CVT® study is the latest part of Boehringer Ingelheim’s innovation in anticoagulation care for patients and physicians. Boehringer Ingelheim launched dabigatran etexilate, the first NOAC for stroke prevention in patients with atrial fibrillation,8 and in 2015 gained approval for idarucizumab, the first and only specific NOAC reversal agent to be approved for use in emergency situations when immediate reversal of the anticoagulant effect of dabigatran is required.9

NOTES TO THE EDITORS

About the RE-SPECT CVT® studyRandomised evaluation of the safety and efficacy of dabigatran etexilate versus dose adjusted warfarin in patients with cerebral venous thrombosis (RE-SPECT CVT®)1
RE-SPECT CVT® is a prospective, randomised Phase III study assessing the safety and efficacy of dabigatran etexilate (Pradaxa®) in patients who suffer from cerebral venous thrombosis (CVT). Involving 180 patients from across Europe and Canada, the open-label study will determine the suitability of dabigatran etexilate versus warfarin (INR 2-3) for the treatment and secondary prevention of blood clots in the veins or venous sinuses of the brain. Patients aged ≥18 years old with a confirmed diagnosis of CVT (with or without haemorrhagic stroke) will be randomised to receive either warfarin or dabigatran etexilate.1 Results of the study are planned to be published in 2019.10

About dabigatran etexilate (Pradaxa®)
Clinical experience of dabigatran equates to more than 5 million patient-years in all licensed indications worldwide.10 Dabigatran has been in the market for more than 7 years and is approved in over 100 countries.10

Currently approved indications for dabigatran are:8,11

Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke

Treatment of DVT and PE and the prevention of recurrent DVT and recurrent PE in adults

In the RE-LY® clinical trial, dabigatran 150mg twice daily showed a similar risk of major bleeding vs. warfarin while dabigatran 110mg twice daily demonstrated a significantly lower rate of major bleeding.4,5 Both doses of dabigatran provide large and significant reductions in intracranial bleeding,4,5 the most feared complication of anticoagulant treatment.12

Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.13,14 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.15 In contrast to vitamin K antagonists, which variably act via different coagulation factors, dabigatran provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.13,15

Dabigatran is the only non-vitamin K antagonist oral anticoagulant with an approved reversal agent, Praxbind® (idarucizumab).9

About idarucizumab (Praxbind®)
Idarucizumab is a humanized antibody fragment, or Fab, designed as a specific reversal agent to dabigatran.16 Idarucizumab binds specifically to dabigatran molecules only, neutralising their anticoagulant effect without interfering with the coagulation cascade.17

In the EU and U.S., idarucizumab is now indicated for patients treated with dabigatran when reversal of the anticoagulant effects of dabigatran is needed:9,18

For urgent procedures / emergency surgery

In life-threatening or uncontrolled bleeding

Phase I data in healthy volunteers as well as in elderly and renally impaired individuals showed that a 5 minute infusion of idarucizumab (>2 g) led to immediate, complete and sustained reversal of dabigatran.17,19 Interim analyses of Phase III data from the emergency setting demonstrated that a single 5g dose of idarucizumab immediately reversed the anticoagulant effect of dabigatran in all patients evaluated.20-22 Thrombotic events occurred in five of the 123 enrolled patients between two to 24 days after idarucizumab administration. None of these patients were receiving antithrombotic therapy at the time of their event. There were 26 total deaths, which appeared to be related to the original reason for emergency admission to the hospital and/or to co-morbidities.22

About Boehringer Ingelheim
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.

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